Najib v. Meridian Medical Technologies, Inc.

NOT RECOMMENDED FOR FULL-TEXT PUBLICATION
File Name: 06a0287n.06
Filed: April 27, 2006
No. 05-3704
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
MOHAMED HISAM NAJIB, )
)
Plaintiff-Appellant, ) ON APPEAL FROM THE UNITED
) STATES DISTRICT COURT FOR
v. ) THE SOUTHERN DISTRICT OF
) OHIO
)
MERIDIAN MEDICAL ) OPINION
TECHNOLOGIES, INC., ET AL., )
)
Defendants-Appellees. )
)
)
_____________________________________
Before: DAUGHTREY and GILMAN, Circuit Judges; RUSSELL, District Judge*
RUSSELL, District Judge. Plaintiff Mohamed Najib appeals the district court’s grant
of summary judgment on his negligence and products liability claims regarding performance of
an “EpiPen” which he used to treat acute asthma attacks. For the following reasons, we
AFFIRM the judgment of the district court with regard to Najib’s supplier-liability and
negligence claims but REVERSE the judgment with respect to Najib’s other claims.
I. BACKGROUND
*
Honorable Thomas B. Russell, United States District Judge for the Western District of
Kentucky, sitting by designation.
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An EpiPen is a product that contains a dose of the drug epinephrine, which is used to
treat anaphylactic shock. Najib’s physician had prescribed the drug for him to use when he
suffered an acute asthma attack. On or about April 19, 1997, he suffered such an attack, but
when he opened the EpiPen, he discovered that it had prematurely ejected. He apparently
suffered no injury as a result of this attack. Shortly thereafter, on or about April 26, 1997, Najib
suffered another acute asthma attack and his fiancee, Julie Campbell, attempted to assist him by
unboxing a new EpiPen and removing it from its outer tube. However, Ms. Campbell was
unable to remove the gray safety cap, and while Najib was attempting to remove it, the Epipen
“fell apart” (Deposition of Julie Campbell, J.A. 598) and became unusable. As a result, Ms.
Campbell and Najib were unable to administer the shot and Najib lost consciousness while
waiting for an ambulance. (Id. at 603). Ms. Campbell was able to resuscitate him, and he was
taken to the emergency room for treatment. (Id. at 609-612). Dr. Kenneth Bain, a
neuropsychologist, opined that the second incident caused hypoxic brain damage. (Deposition of
Kenneth Bain, J.A. 526-528).
Najib’s Complaint alleged the following: in Counts One and Two, negligence in design,
manufacture, and failure to warn; in Count Three, failure to conform to representation; in Count
Four, supplier liability; and in Count Five, breach of implied warranty of merchantability. (J.A.
15-22). Counts Two, Three and Four included violations of Ohio’s products liability statute.
(Id.).
The district court granted summary judgment on all of Najib’s claims. In so doing, the
district court held that the testimony of Jack Raber, a pharmacist, was irrelevant. The district
court also held that the testimony of Najib’s expert, Dr. Reese, was inadmissible because it
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would not help the trier of fact and further held that this failure to produce admissible expert
testimony was fatal to his claims.
II. STANDARD OF REVIEW
This court reviews de novo a district court’s award of summary judgment. Barrett v.
Harrington, 130 F.3d 246, 251 (6th Cir. 1997). Summary judgment is proper if the evidence
submitted shows that there is no genuine issue of material fact and that the moving party is
entitled to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986).
This Court must view the entire record in the light most favorable to the non-moving party.
Smith v. Chrysler Corp., 155 F.3d 799, 804 (6th Cir. 1998). This court reviews the district
court’s decisions to exclude the testimony of Dr. Reese and Mr. Raber for abuse of discretion.
See, e.g., General Electric Co. v. Joiner, 522 U.S. 136, 141, 118 S. Ct. 512, 517, 139 L. Ed. 2d 508
(1997).
III. ANALYSIS
A. Admissibility of Dr. Reese’s testimony
The district court’s Opinion and Order (J.A. 473) indicates that, although it found Dr.
Reese to be qualified to receive an expert designation, it did not find that his testimony would be
helpful to a jury in “determin[ing] whether and how the EpiPens were defective.” (J.A. at 480-
81). With regard to Najib’s claims of negligent design and manufacture, the district court listed
three ways in which a product’s design could be defective. One is where the product “is more
dangerous than an ordinary consumer would expect ... or ... the benefits of the challenged design
do not outweigh the risk inherent in such design.” (J.A. at 481, quoting City of Cincinnati v.
Beretta U.S.A. Corp., 768 N.E.2d 1136, 1146 (Ohio 2002)). A second is “where the
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manufacturer fails to incorporate feasible safety features to prevent injuries.” (J.A. at 482, citing
Perkins v. Wilkinson Sword, Inc., 700 N.E.2d 1247 (Ohio 1998)). The third such situation
occurs when “a product ... differs in a material way from its design specifications or from
otherwise identical units.” (J.A. at 482, citing Kemp v. Medtronic, Inc., 1999 U.S. Dist. LEXIS
22470, at * 24 (S.D. Ohio 1999)).
In light of these possibilities, the district court examined Dr. Reese’s testimony and
determined that it amounted to his “opinion ... that something malfunctioned, but he did not
know what.” (J.A. at 482-3). The district court noted that Dr. Reese “did not even review the
EpiPen’s design specifications or manufacturing procedures,” which it said “prevented him from
addressing whether and how the EpiPen differed in a material way from its design specifications
or from otherwise identical units.” (J.A. at 483). It also said that Dr. Reese’s testimony did not
address the first or third possible bases for a finding of negligence in design or manufacture
listed above. (Id.). As to the failure to warn, the district court said that because Dr. Reese was
“unable to identify the alleged defect,” Najib had “failed to prove that Defendants knew or
should have known about a defect” and granted summary judgment on that claim. (J.A. at 484).
Similarly, with respect to the claim of failure to provide usable instructions, the district court
said that “[b]ecause [Dr. Reese’s] report fails to detail how the instructions were unclear, his
conclusion [that they were inadequate] is irrelevant.” (Id.).
Addressing the claim of a defect in manufacture or construction, the district court found
that Najib could not satisfy the first prong of the test set forth in the statute (which requires him
to establish by a preponderance of the evidence that there was a defect in the product) because
“[Dr.] Reese cannot state what the alleged defect was.” (J.A. at 485). The district court granted
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summary judgment on that claim, as well as the claims for failure to conform to representations
and the breach of implied warranty of merchantability, on essentially the same grounds.
Examination of Dr. Reese’s report (J.A. 348) and deposition testimony (J.A. 762) indicates that
the district court correctly interpreted Dr. Reese’s testimony. Although Dr. Reese did discuss
possible alternate designs and alternate labeling/packaging possibilities in his report, such
discussion amounts essentially to speculation where the actual defect in a product is not
identified. Therefore, it appears that the district court did not abuse its discretion in excluding
Dr. Reese’s testimony.
B. Sufficiency of Najib’s admissible evidence
A separate issue, addressed although not so delineated by the parties, is whether, even
exclusive of Dr. Reese’s testimony, summary judgment on Najib’s claims was appropriate.
Najib argues that the circumstantial evidence of a defect in the case (i.e., the evidence that the
gray cap became stuck and the EpiPen fell apart) is sufficient to create an issue for the jury. In
response, Meridian argues only that “Plaintiff is not qualified to testify regarding the technical
aspects of the Epi-pen’s design or components, its manufacture ...” and that “Plaintiff’s
testimony by itself is insufficient, as a matter of law, to sustain his claim for design or
manufacturing defect.” (Defendant-Appellant’s Brief, at 15).
A careful reading of the district court’s opinion indicates that it did not consider the
possibility that the circumstantial evidence could be sufficient to withstand the summary
judgment motion. As Plaintiff correctly asserts, Ohio law provides for this possibility. In State
Farm Fire & Cas. Co. v. Chrysler Corp., the Supreme Court of Ohio said that
[w]here direct evidence [of a product defect] is unavailable, a defect in a
manufactured product existing at the time the product left the manufacturer may
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be proven by circumstantial evidence where a preponderance of that evidence
establishes that the loss was caused by a defect and not other possibilities,
although not all other possibilities need be eliminated.
523 N.E.2d 489, 493-94, 37 Ohio St. 3d 1, 5 (Ohio 1988). In that case, which involved a fire of
unknown origin that broke out in the plaintiff’s vehicle while it was parked, the Supreme Court
of Ohio affirmed a directed verdict in favor of the car’s manufacturer because the circumstantial
evidence that did exist failed to rule out a number of causes (maintenance, etc.) and therefore
could not causally link the fire to a defect in the car’s manufacture. Id. at 495. In this case, the
destruction of the EpiPen as a result of its failure rendered direct evidence unavailable, meaning
circumstantial evidence may be used to establish that the EpiPen was defective. The district
court’s opinion, however, does not address this possibility. Rather, it examines only the expert
testimony offered by Plaintiffs and grants summary judgment on the basis of its exclusion of that
testimony. This is understandable in light of the fact that the arguments before the district judge
concerned primarily the admissibility of the expert testimony. However, Najib did raise the
circumstantial evidence argument. The district court said:
...the Court holds that [Dr. Reese’s] testimony and report will not help the trier of
fact determine whether the EpiPen was negligently designed or manufactured.
Accordingly, the Court grants the Defendants’ motion for summary judgment on
these claims.
(J.A. at 483). The district court made similar statements in its analysis of several of Najib’s
other claims. (J.A. at 484, 485, 487).
We believe, however, that the circumstantial evidence in Najib’s case is significantly
different from that presented in State Farm because he presented testimony that excludes other
possible causes for the EpiPen’s malfunction. He and his fiancee both testified that the EpiPen
in question was new, had not previously been removed from its box, and that they knew how to
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remove the cap. Therefore, we believe that Najib’s case is more similar to the situation
described by the Ohio Court of Appeals in Hickey v. Otis Elevator Co. in which proof of
causation by circumstantial evidence was held to be appropriate for jury determination. 840
N.E.2d 637, 641-42, 163 Ohio App. 3d 765, 770-71 (Ohio Ct. App. 2005). In that case, the Court
of Appeals distinguished between cases in which the issue of causation is complicated by virtue
of the nature of the product at issue (Hickey dealt with a malfunctioning elevator) and those in
which a jury could reasonably infer causation from the circumstantial evidence because the
product itself was relatively simple (citing Porter v. Gibson Greetings, Inc., 1997 WL 761851
(Ohio App. 2 Dist. 1997), which dealt with an ordinary balloon). Id. Therefore, we believe that
the district court’s opinion inappropriately granted summary judgment on the issue of defect
where an issue of material fact exists. We note that we express no opinion on the issue of
causation, as that issue is not before us at this time.
We note, however, that, under Ohio law, the use of circumstantial evidence to prove the
element of defect is allowable in the context of products liability claims, but is insufficient to
prove negligence. Gast v. Sears Roebuck & Co., 313 N.E.2d 831, 39 Ohio St. 2d 29 (Ohio 1974).
Therefore, as to Najib’s negligence claims, the district court’s grant of summary judgment for
failure to introduce evidence of breach was appropriate in light of its evidentiary rulings.
C. Admissibility of Mr. Raber’s testimony
Plaintiff offered the testimony of Jack Raber, a pharmacist. As to the admissibility of
Mr. Raber’s testimony, the district court’s opinion says:
Plaintiff offers the deposition testimony of Raber, a pharmacist, to establish that
the EpiPen could be used to treat asthma attacks. Thus, Raber did not testify to
Plaintiff’s manufacturing or design defect claims, nor did his testimony address
Plaintiff’s inadequate warning and instruction claims. Because the Court
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excluded [Dr. Reese’s] report and testimony above, Plaintiff is unable to establish
that the EpiPen malfunctioned. Consequently, [Mr. Raber’s] testimony becomes
irrelevant and the Court grants the Defendants’ motion for summary judgment for
lack of evidence.
(J.A. 488). The district court based its evaluation of Mr. Raber’s testimony’s relevance on its
conclusion that Plaintiff had failed to survive summary judgment due to the shortcomings of Dr.
Reese’s testimony. However, as discussed in Section B, supra, the district court erroneously
failed to consider circumstantial evidence in making this determination. Therefore, the relevance
of Mr. Raber’s testimony may also need to be reconsidered in light of the district court’s
consideration of that evidence.
D. Supplier-liability claim
As noted above, count four of Najib’s complaint alleged supplier-liability against
Meridian. Under Ohio law, Meridian cannot be considered both the EpiPen’s manufacturer and
its supplier. Ohio’s products liability statute specifically provides, in its definition of “supplier,”
that the term “does not include ... a manufacturer.” Ohio Rev. Code Ann. § 2307.71(15)(b).
Therefore, the district court’s grant of summary judgment on this claim was proper.
III. CONCLUSION
For the foregoing reasons, we AFFIRM the district court’s order granting summary
judgment to the Defendants on Najib’s supplier-liability claim and negligence claims, and
REVERSE the grant of summary judgment on the issue of defect as to the remaining claims.
We therefore REMAND the case for further proceedings consistent with this opinion.
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